Mirapex PD, 1.5 mg, 30 pcs.

Active substance: 

pramipexole dihydrochloride monohydrate 1.5 mg;

Excipients: 

hypromellose 2208, 

corn starch,

carbomer 941,

silica colloidal 

magnesium stearate.

Mirapex PD - an antiparkinsonian drug - an agonist of dopamine receptors. It binds to dopamine receptors of the D2 subgroup with high selectivity and specificity, of which it has the most pronounced affinity for D3 receptors. 

Reduces deficiency of motor activity in Parkinson's disease by stimulating dopamine receptors in the striatum. Pramipexole inhibits dopamine synthesis, release and metabolism. In vitro pramipexole protects dopamine neurons from degeneration in response to ischemia or methamphetamine neurotoxicity.

Pramipexole in vitro protects neurons from the neurotoxicity of levodopa.

Reduces the secretion of prolactin (dose-dependent).

In clinical studies on healthy volunteers, in whom the dose of Mirapex PD was increased faster than it should (every 3 days), up to 4.5 mg / day, an increase in blood pressure and heart rate was observed. In studies on patients, this effect was not observed.

Pharmacokinetics

Suction and distribution

Pramipexole after oral administration is rapidly and completely absorbed. Absolute bioavailability exceeds 90% and plasma Cmax is reached after approximately 6 hours. As a rule, food intake does not affect the bioavailability of pramipexole. 

After ingestion of fatty foods, there is a slight increase, by approximately 20%, of Cmax and a slowdown of approximately 2 hours of the time to reach Cmax, which have no clinical significance.

Pramipexole exhibits linear kinetics and relatively small plasma level variability between patients, regardless of pharmaceutical form. Pramipexole binds to plasma proteins to a very small extent (

Metabolism and excretion

It is slightly metabolized.

About 90% of the dose is excreted through the kidneys (80% unchanged) and less than 2% is found in feces. The total clearance of pramipexole is about 500 ml / min, renal clearance is about 400 ml / min. T1 / 2 fluctuates from 8 hours in young and up to 12 hours in older people.

Parkinson's disease.

It is possible if the expected effect of therapy exceeds the potential risk to the fetus (adequate and well-controlled studies on the use during pregnancy have not been carried out).

The FDA category of action on the fetus is C.

At the time of treatment, breastfeeding should be stopped (there are no data on penetration into breast milk in humans).

Hypersensitivity

From the nervous system and sensory organs: asthenia, drowsiness / insomnia, hallucinations, delirium, amnesia, confusion, dizziness, anxiety, depression, dysphagia, dystonia, akathisia, impaired thinking, suicidal mood, extrapyramidal syndrome, dyskinesia, tremor, hyposthesia, hypokinesia, myoclonus, ataxia, impaired coordination of movements, diplopia, accommodation paralysis, conjunctivitis, hearing impairment; in isolated cases (with rapid dose reduction or abrupt cancellation) - malignant antipsychotic syndrome (hyperthermia, muscle rigidity, impaired consciousness, autonomic lability).

From the cardiovascular system and blood (hematopoiesis, hemostasis): orthostatic hypotension, tachycardia, arrhythmia.

From the respiratory system: shortness of breath, rhinitis, pharyngitis, sinusitis, flu-like syndrome, increased cough.

From the digestive tract: nausea, vomiting, dyspepsia, flatulence, diarrhea, dry mouth, anorexia, constipation.

From the musculoskeletal system: muscle hypertonicity, cramps in the muscles of the legs, muscle twitching, myasthenia gravis, arthritis, bursitis.

Other: fever; peripheral edema, sweating, increased intraocular pressure, decreased libido, impotence, weight loss; increased urination, urinary tract infections; pain syndrome, including chest pain, abdominal pain, pain in the lumbosacral spine, neck pain; voice change; increased activity of CPK; allergic reactions.

Pramipexole to a small extent

Drugs that inhibit the active secretion of cationic drugs through the renal tubules (for example, cimetidine), or which themselves are eliminated by active secretion through the renal tubules, can interact with pramipexole, which translates into reduced clearance of one or both drugs. 

In the case of the simultaneous use of such drugs (including amantadine) and pramipexole, it is necessary to pay attention to such signs of excessive dopamine stimulation as dyskinesia, agitation or hallucinations. In such cases, it is necessary to reduce the dose.

Selegiline and levodopa do not affect the pharmacokinetics of pramipexole. Pramipexole does not affect the total absorption or elimination of levodopa. Interactions with anticholinergic drugs and amantadine have not been studied. 

However, interaction with amantadine is possible, because drugs have a similar excretion mechanism. Anticholinergic drugs are mainly excreted by the metabolic route, so interaction with pramipexole is unlikely.

With an increase in the dose of the drug in patients with Parkinson's disease, it is recommended that the dose of levodopa be reduced, while the dose of other antiparkinsonian drugs must be kept constant.

Due to possible cumulative effects, patients should be advised to be careful when taking other sedative drugs or alcohol in combination with Mirapex PD, and also while taking drugs that increase the concentration of pramipexole in the plasma (e.g. cimetidine).

Sustained-release tablets should be taken 1 time per day, approximately at the same time of the day. The tablets are swallowed whole, washed down with water, tablets cannot be chewed, broken or crushed. Tablets can be taken without regard to meals.

If the time of the next administration of the drug was missed, then if more than 12 hours have not passed since the usual time of administration, the drug should be taken in a daily dose. If more than 12 hours have passed, then the drug should not be taken, the next dose should take place the next day at the usual time.

Patients who are already taking Mirapex tablets can be taken to take Mirapex PD extended-release tablets during the day, in the same dose.

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